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The last few years have been especially difficult for suppliers of orthotic braces. As orthoses continue to be at the top of CMS’ list of audited codes, auditors continue to find new and creative ways to deny claims. As of late, denials related to telehealth services have topped the list of denial reasons. Medicare payment for telehealth services is clearly defined. First, the beneficiary must reside in a rural Health Professional Shortage Area (HPSA). Second, the physician must provide the telehealth consult in an approved facility using an interactive audio and video telecommunication system. Lastly, the beneficiary must participate in the telehealth visit from an approved, originating site. In most cases, however, these claims are not telehealth services but rather telephone consults. More often, these consults are the result of lead-generation services and direct-to-beneficiary marketing for orthotics that are being dropped shipped to beneficiaries nationally. While there is nothing wrong with marketing directly to beneficiaries or using lead-generation services, the contractual arrangement between the supplier and the marketing company could leave you, the supplier, in violation of paying the physician for the referral or the encounter. How is that possible? Take a look at the process chart below. Strip all of the above steps away and you may have violated the Anti-Kickback Statute. Also, because the physicians do not have any established relationships with the patients and often times are located nowhere near the patient, it’s easily detectable in your claims data. You, the supplier, cannot contract with another entity to do what you are not allowed to do yourself. If you pay the lead generation service for the referral and they pay the physician for the evaluation, then YOU have unwittingly paid for the referral. As you know, that is violation of the Anti-kickback Statute which carries criminal penalties of up to 5 years in prison and criminal fines up to $25,000 per violation and civil monetary penalties of up to $50,000 per violation. Additionally, the Department of Health and Human Services’ Office of Inspector General may commence administrative proceedings to prohibit anyone convicted of an Anti-Kickback violation from participation in federal and state health care programs or impose civil monetary penalties for fraud, kickbacks, and other prohibited activities. Another thing to consider is that many of these companies will make claims that an attorney or consultant has reviewed and approved their process. If so, get the name and telephone number of who that attorney or consultant, contact that person, and ask for evidence of such in writing. You’ll likely find that such a review hasn’t occurred. As I mentioned previously, these codes are being heavily targeted, increasingly by the UPICs. Entering into an arrangement like this and dramatically increasing your billing in this product category will quickly put a target on your back that could lead to increased audits, denials, extrapolated overpayments, payment suspensions, or revocations. We have seen good suppliers get caught up in this mess and the entities they engaged with have no liability, as they have not submitted any claims to the government. If a service tells you that they will provide the lead, orders, medical records, etc. and that all you have to do is submit the claim to the government for payment, take heed of this warning! The potential for a false claim violation or improper payment occurs upon claim submission. They have no liability in the process and leave you holding the bag. Some of these companies may even engage in suspect activity including cold-calling, which is a direct violation of the Supplier Standards, and puts your supplier number at risk. Don’t get caught up in this. If you engage a lead generation service, conduct your due diligence on their processes, engage your own counsel to review all contracts and marketing materials, and perform regular evaluation of their telephone calls and procedures. Make sure you scrutinize the referrals and understand where they came from. A legitimate lead generation service should have no problem providing this information. If the calls with beneficiaries are recorded, request to listen to the calls to ensure that solicitation is not occurring. If you have questions please call The van Halem Group at (404) 343-1815.